Archive → FDA PCCP

Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions

Version 2026-07-29, retrieved 2026-07-29.

Instrument

FDA PCCP

Version

2026-07-29

Published

—

Retrieved

2026-07-29

Last checked

2026-07-29

Original URL

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence↗ (opens in new tab) · retrieved 28 Jul 2026

Archive copy

not yet archived

SHA-256

fc317e8a7ce4bbf8c83f1d50ab5315b40e29ee431477835f712ca419c0222b9c

Size

37,188 bytes

Type

text/html

What this record is

The document itself is not reproduced here. This record states that the file at the original URL was retrieved on the date shown and had the SHA-256 given. Anyone holding a copy can compute that hash and confirm it is the same file that was read on that date.

Last updated: 28 July 2026